LY4337713 for people with FAP-positive ovarian, breast, pancreatic, colorectal, or esophageal cancers

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

LY4337713 is a lutetium-177–labeled agent designed to bind fibroblast activation protein (FAP) in the tumor microenvironment and deliver targeted radiation. This Phase 1 interventional trial enrolls adults with selected advanced or metastatic solid tumors that are confirmed FAP-positive to characterize safety, side effects, and early signs of anti-tumor activity. The study includes pharmacokinetic sampling to measure how the drug enters the bloodstream, is metabolized, and is cleared, and participants are followed for about five years. Treatment is administered at participating U.S. sites with dosing and schedule determined by the phase 1 protocol.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Must have clinical or imaging evidence of fibroblast activation protein (FAP) expression per local assessment
* Must have histologically or cytologically confirmed diagnosis of one of the following:

  * Adenocarcinoma of the pancreas
  * Hormone receptor (HR)-positive human epidermal growth factor 2 (HER2)-negative breast cancer
  * HER2-positive breast cancer
  * Triple negative breast cancer (TNBC)
  * Platinum-resistant or refractory ovarian cancer (including ovarian carcinosarcoma)

    * Gastric cancer (adenocarcinoma)
    * Colorectal cancer (CRC)
    * Esophageal cancer (squamous cell carcinoma or adenocarcinoma)
    * Cholangiocarcinoma
    * Other non- central nervous system (CNS) solid tumors, which have demonstrated FAP uptake via positron emission tomography (PET),
* Must have received prior treatments as indicated below:

  * Phase 1a

    * Adenocarcinoma of the pancreas: Participants must have received at least 1, but no more than 2 prior regimens for locally advanced unresectable or metastatic disease.
    * HR-positive HER2-negative breast cancer: Participants must have received less than or equal to (≤)5 prior lines of treatment for advanced or metastatic disease, which must include a cyclin-dependent kinase 4/6 inhibitor.
    * HER2-positive breast cancer: Participants must have received at least 2 lines of HER2-targeted therapy, which should include at least 1 antibody-drug conjugate (ADC) for metastatic disease (if locally available).
    * TNBC: Participants must have received at least 1 prior line of therapy for metastatic disease, and must have received an ADC unless unavailable, ineligible, or refused.
    * Platinum-resistant or refractory ovarian cancer: Participants must have received or after at least 1 platinum-based therapy.
    * Gastric cancer, CRC, esophageal cancer (squamous cell carcinoma or adenocarcinoma), and cholangiocarcinoma: Participants must have received greater than or equal to (≥)1 prior line of systemic therapy for advanced or metastatic disease; this may include, but does not require, prior line(s) in combination with immunotherapy or vascular endothelial growth factor inhibitor.
    * Other non-CNS solid tumors: Participants must have exhausted, be ineligible for, or refused all standard-of-care therapy appropriate for their disease.
  * Phase 1b:

    * Participants must have advanced or metastatic solid tumors and have received ≥1 prior line of therapy.
* Must have an Eastern Cooperative Oncology Group Performance Status (ECOG PS) of 0 to 1.
* Measured creatinine clearance ≥60 milliliters per minute (mL/min)

Exclusion Criteria:

* Have known active central nervous system (CNS) metastases or carcinomatous meningitis.
* Have significant cardiovascular disease
* Have prolongation of the corrected QTcF \>470 milliseconds (msec) during screening. QTcF is calculated using Fridericia's Formula: QTcF = QT/(RR0.33)
* Have evidence of ongoing and untreated urinary tract obstruction
* Had previous hemi- or total-body radiation.
* Had previous adoptive T-cell therapy (e.g., chimeric antigen receptor T-cell \[CAR-T therapy, T-cell receptor \[TCR\] therapy, etc.)
* Unable to lie flat during, or otherwise tolerate, single photon emission computed tomography (SPECT), positron emission tomography (PET), computed tomography (CT) or magnetic resonance imaging (MRI).

Where it's running

• Hoag Memorial Hospital Presbyterian
  Newport Beach, California, United States Recruiting
• Stanford University Medical Center
  Stanford, California, United States Recruiting
• Moffitt
  Tampa, Florida, United States Recruiting
• Indiana University (IU) School of Medicine
  Indianapolis, Indiana, United States Recruiting
• United Theranostics
  Glen Burnie, Maryland, United States Recruiting
• Massachusetts General Hospital
  Boston, Massachusetts, United States Recruiting

Study contacts

• Study coordinator: Trial questions or participation questions: 1-877-CTLILLY (1-877-285-4559) or
• Email: LillyTrials@Lilly.com
• Phone: 1-317-615-4559

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.